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NCT Number: NCT04282512

Evaluation of the Effect of Sodium Bicarbonate Water on Blood Pressure in Normotensive Subjects

ROX_TENSIO18 is a randomised cross-over trial and the main objective is to evaluate the effect of daily consumption of sodium bicarbonate water for 15 days on blood pressure.

Secondary objective are:

* Evaluation of the effect of daily consumption of sodium bicarbonate water on total salt intake * Evaluation on blood pressure of the usual food groups that are the strongest contributors of salt intake.

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Key information

Conditions

Blood Pressure

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Diabétologie Et Nutrition Du Centre

Mainvilliers, 28305, France

About this study

Volunteers are normotensive subjects divided into two equivalent groups. Group A subjects will begin their first 15-day period with the consumption of St-Yorre mineral water.

Group B will begin the first 15-day period by drinking tap water. After a washout period of 15 days, each group alternates with a new period of 15 days of water consumption monitoring: tap water for group A and mineral water St-Yorre for group B.

For each period salt intake and blood pressure are measured.Three-day food records are also performed for both 15-days periods.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Normal blood pressure between 90/60 and 140/90 mm Hg
  • Usually drinks tap water;
  • Knowing read and write French routinely,
  • Possessing an internet connection at home,
  • Possessing and knowing how to use a computer or tablet,
  • Affiliated with a social security scheme
  • Not Trust
  • Having signed the informed consent letter

Exclusion criteria

  • Pregnant or lactating woman
  • BMI greater than 35 kg / m²
  • Heart failure
  • History of cardiovascular disease
  • Hypertension treated or untreated
  • Renal failure.

Treatment and study plan

Sodium bicarbonate-rich mineral water

Other

St-Yorre, a sodium bicarbonate-rich mineral water, is a commercial mineral water that contains 4368 mg/l sodium bicarbonate. The study intends to evaluate the effect on blood pressure of the sodium bicarbonate intake due to this mineral water consumption.

Other names: St-Yorre mineral water

Primary outcomes

  1. Change from baseline mean number of systolic and diastolic blood pressure at 15 days

    Time frame: Day 1 to Day 3 - Day 13 to Day 15- Day 31 to Day 33 - Day 43 to Day 45

    The primary endpoint is the difference between mean number of blood pressure of the volunteers drinking sodium bicarbonated-rich water during 15 days and the mean number of volunteers drinking tap water during 15 days.

Secondary outcomes

  1. Sodium intake

    Time frame: Day 1 to Day 15 - Day 31 to Day 45

    The sodium intake per day is assessed using two three-day food records and the ExSel test.

Sponsors and collaborators

Lead sponsor

My Goodlife SAS

Industry

Registry information

Official study title

Evaluation of the Effect of Daily Consumption of Sodium Bicarbonate Water for 15 Days on Blood Pressure in Normotensive Subjects

Acronym: ROX_TENSIO18

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 24, 2020
Registry last updated
Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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